Cytalux™ for Prostate Cancer

No longer recruiting at 2 trial locations

Overseen By Jennifer Lehman, RN

Age: 18+

Sex: Male

Trial Phase: Phase 2

Sponsor: Clinton Bahler

Disqualifiers: Extraperitoneal approach, Anaphylactic reactions, Allergy to pafolacianine, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

Duration: 1 day

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether Cytalux™ (pafolacianine), combined with special imaging technology, can better identify cancerous tissue in men undergoing prostate cancer surgery. Cytalux™ already aids in surgeries for ovarian and lung cancers by helping doctors see cancerous areas more clearly. Men with confirmed prostate cancer who are scheduled for surgery might be suitable candidates. Participants must stop taking folate or folic acid supplements two days before receiving the trial treatment. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to important advancements in prostate cancer surgery.

Will I have to stop taking my current medications?

The trial requires participants to stop taking folate or folic acid supplements at least 48 hours before receiving the study agent. Other medications are not specifically mentioned, so it's best to discuss with the trial team.

Is there any evidence suggesting that Cytalux™ is likely to be safe for humans?

Research has shown that Cytalux™ (pafolacianine) is generally well-tolerated. The FDA has approved it for use in surgeries for ovarian and lung cancer, indicating its safety for those applications. However, like many treatments, it can cause side effects. Reported reactions include nausea, vomiting, stomach pain, flushing, indigestion, chest discomfort, and allergic reactions.

These side effects are important to consider but are common with many medical treatments. The approval for other cancers provides extensive safety information, although patients with prostate cancer might experience different reactions. This trial aims to determine how safe and effective Cytalux is for prostate cancer specifically. Patients should always consult a healthcare provider about potential risks and benefits before joining any clinical trial. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Most treatments for prostate cancer, such as surgery, radiation, and hormone therapy, focus on removing or shrinking tumors. But Cytalux™ offers a unique approach by using pafolacianine, a fluorescent dye, to help surgeons see cancerous tissue more clearly during surgery. This enhanced visibility can lead to more precise removal of cancerous cells, potentially reducing the risk of recurrence. Researchers are excited about Cytalux™ because it could significantly improve surgical outcomes by ensuring that more cancerous tissue is effectively targeted and removed.

What evidence suggests that Cytalux™ might be an effective treatment for prostate cancer?

Research has shown that Cytalux™ (pafolacianine) received FDA approval for use in surgeries for ovarian and lung cancer. This approval stems from its ability to help surgeons see cancerous tissues more clearly with a special imaging technique. In this trial, researchers are testing Cytalux™ for prostate cancer, where participants will receive a pafolacianine injection followed by surgery. Cytalux™ aims to make cancer cells glow during surgery, aiding doctors in finding and removing them more accurately. Early results suggest this imaging agent holds promise for better detecting cancerous tissue, which is crucial in cancer treatment. ^{1 4 6 7 8}

Who Is on the Research Team?

Clinton Bahler, MD

Principal Investigator

Indiana University

Are You a Good Fit for This Trial?

This trial is for adults with biopsy-confirmed prostate cancer who are undergoing prostatectomy and lymph node dissection. Details about specific inclusion or exclusion criteria are not provided, but typically participants must meet certain health standards and not have conditions that would interfere with the study.

Inclusion Criteria

I am a man aged 18 or older.

Signed and dated informed consent form

My prostate cancer is aggressive and may have spread beyond the prostate.

Exclusion Criteria

My surgeon will operate outside the peritoneal cavity.

Any medical condition that in the opinion of the investigators could potentially jeopardize the safety of the subject

History of anaphylactic reactions to products containing indocyanine green

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo laparoscopic radical prostatectomy with NIR imaging using pafolacianine

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after surgery

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• CYTALUX™

Trial Overview The trial is testing Cytalux™ (pafolacianine) used alongside NIR fluorescent imaging to see if it helps better identify cancerous tissue during surgery in patients with prostate cancer. The FDA has previously approved this agent for ovarian and lung cancer surgeries.

How Is the Trial Designed?

Group I: Pafolacianine injection and surgery Experimental Treatment 2 Interventions

Who Is Running the Clinical Trial?

Clinton Bahler

Lead Sponsor

Trials

3

Recruited

80+

Indiana University

Lead Sponsor

Trials

1,063

Recruited

1,182,000+

On Target Laboratories

Collaborator

Trials

2

Recruited

30+

On Target Laboratories, LLC

Industry Sponsor

Trials

8

Recruited

470+

Published Research Related to This Trial

Prostate cancer is a common malignancy in men over 50, primarily presenting with urinary issues, and is mostly treated effectively with prostatectomy or irradiation when localized, leading to a good prognosis.

Hormonal manipulation is the main treatment for metastatic prostate cancer, with 70-80% of patients responding to therapies like orchiectomy and LHRH analogs for up to three years, although responses diminish significantly after relapse.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment of prostate cancer. Korman, LB.[2005]

In a study involving 304 patients with advanced prostate cancer, there was no significant difference in overall and progression-free survival between those treated with Zoladex alone and those treated with Zoladex plus flutamide.

The combination treatment of Zoladex and flutamide resulted in a higher response rate and quicker relief of bone pain, but it also led to more side effects, suggesting that the combination may not provide a clear advantage over Zoladex alone.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Zoladex with or without flutamide in the treatment of locally advanced or metastatic prostate cancer: interim analysis of an ongoing PONCAP study. Italian Prostatic Cancer Project (PONCAP). Boccardo, F., Decensi, A., Guarneri, D., et al.[2019]

In a trial involving advanced metastatic prostate cancer, the combination treatment of the LHRH agonist buserelin and cyproterone acetate showed no significant difference in response rates, progression time, or survival compared to orchidectomy, indicating similar efficacy among the treatment options.

The use of cyproterone acetate alongside buserelin was aimed at preventing disease flare-ups and reducing side effects like hot flushes, but ultimately did not improve outcomes compared to surgical removal of the testes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Maximum androgen blockade using LHRH agonist buserelin in combination with short-term (two weeks) or long-term (continuous) cyproterone acetate is not superior to standard androgen deprivation in the treatment of advanced prostate cancer. Final analysis of EORTC GU Group Trial 30843. European Organization for Research and Treatment of Cancer (EROTC) Genito-Urinary Tract Cancer Cooperative Group. de Voogt, HJ., Studer, U., Schröder, FH., et al.[2019]

In the phase 3 HERO trial involving patients with advanced prostate cancer, relugolix showed superior sustained testosterone suppression compared to leuprolide over a 48-week period.

Relugolix also allowed for faster testosterone recovery after treatment discontinuation and was associated with a 50% reduction in major adverse cardiovascular events (MACE), highlighting its potential safety benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Phase 3 HERO Trial Finds Relugolix to Be Superior to Leuprolide in Prostate Cancer. Slater, H.[2021]

New treatments for advanced prostate cancer are on the horizon, including hormonal therapies like Abiraterone and MDV3100, which target hormone pathways to slow cancer growth.

Innovative options such as the chemotherapy Cabazitaxel and the cellular vaccine Sipuleucel-T are being explored, alongside anti-angiogenic drugs and new radioactive treatments, indicating a multi-faceted approach to combatting this challenging disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[New drugs at the horizon for men with prostate cancer]. Shabafrouz, K., Bauer, J., Berthold, DR.[2010]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06434909?term=PAFOLACIANINE&viewType=Table&rank=1

CYTALUX™for the Intraoperative Imaging of Prostate Cancer An entry on ClinicalTrials.gov that contains a summary of a clinical study's protocol information, including the recruitment status; eligibility criteria; ...

2. trialfinder.panfoundation.org trialfinder.panfoundation.org/en-US/trial/listing/494217

CYTALUX™for the Intraoperative Imaging of Prostate Cancer This study is being done to compare how much using Cytalux™ (pafolacianine) with NIR (Near InfraRed) fluorescent imaging improves the ...

3. cancer.iu.edu cancer.iu.edu/patients/clinical-trials/62298

UROL-CC-IUSCCC-0890: Clinical Trial Information An Investigator Sponsored Study to Investigate the Safety and Efficacy of CYTALUX (PAFOLACIANINE) INJECTION for the Intraoperative Imaging of Prostate Cancer ...

4. withpower.com withpower.com/trial/early-phase-1-prostatic-neoplasms-6-2024-c31eb

Cytalux™ for Prostate Cancer In the phase 3 HERO trial involving patients with advanced prostate cancer, relugolix showed superior sustained testosterone suppression compared to leuprolide ...

5. ontargetlabs.com ontargetlabs.com/new-study-shows-cytalux-clinical-trial-findings-translate-to-the-real-world/

New Study Shows CYTALUX® Clinical Trial Findings ... The results from the CYTALUX clinical trials have successfully translated into and been confirmed by real-world experiences.

6. cancer.gov cancer.gov/research/participate/clinical-trials-search/v?id=NCI-2024-09308

Cytalux with Near Infrared Light for Intraoperative Imaging ... Cytalux is designed to bind to the prostate cancer cells, and this makes them “glow” under the NIR light, making it easier to detect and remove the prostate ...

7. cytalux.com cytalux.com/important-safety-information/

CYTALUX Important Safety Information Adverse reactions including nausea, vomiting, abdominal pain, flushing, indigestion, chest discomfort, and allergic reactions were reported during the ...

8. research-studies.allinforhealth.info research-studies.allinforhealth.info/us/en/listing/12763/an-investigator-sponsored-study/

An Investigator Sponsored Study to Investigate the Safety This is an open label trial in up to 15 subjects with biopsy confirmed prostate cancer (PCa) who have been scheduled to undergo a laparoscopic ...